Lilly set to head to regulators with CGRP migraine drug

Gathers three positive late-stage trials of galcanezumab as it chases Amgen

Three positive phase III trials put Eli Lilly on course to file its CGRP inhibitor galcanezumab later this year, as it tries to shorten Amgen's lead for this type of migraine drug.

The trio of studies - EVOLVE 1 and 2 and REGAIN - show that galcanezumab was able to cut the number of days in a month that patients suffer a migraine attack significantly compared to placebo, setting up a marketing application in the US in the second half of 2017.

Across the three studies, Lilly's drug typically reduced the number of migraine days by between four and five per month, compared to a reduction of two to three days with placebo.

"The impact of migraine is underestimated, with people who experience migraine attacks often missing work, family activities or social engagements," said Lilly Bio-Medicines president Christi Shaw. "For patients with as few as one migraine headache day per week, this can mean more than 50 days of lost productivity a year."

Lilly is playing catch-up in the CGRP inhibitor sector with Amgen and partner Novartis, whose erenumab is set for approval in 2018, with Teva and Alder Biopharmaceutical also bringing candidates through the pipeline and due to report phase III data in the next 12 to 18 months.

There is a lot at stake. Market research firm Decision Resources predicts CGRP inhibitors will have a dramatic impact on the migraine market, helping it to grow from a value of around $3bn in 2015 to more than $10bn in 2025 in seven key markets - the US, France, Germany, Italy, Spain, the UK and Japan. All told, the CGRP inhibitors should account for around $4.5bn of that total, it suggests.

With four candidates heading to market within a year or two of each other, competition is expected to be pretty tough – which may explain why Amgen handed over a bigger chunk of international rights to the drug to Novartis last month.

That decision could reflect a realisation that sales for even the front-runner may not be as high as hoped, and that additional marketing muscle will be required to carve out a share in the market, according to a recent research note from analysts at Bernstein.

Lilly recently added to its galcanezumab programme in migraine by buying CoLucid and its lead drug lasmiditan, an oral serotonin 5-HT 1F agonist that is due to be filed for approval in 2018.